Transcranial Focused Ultrasound for Depression and Anxiety

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Pregnancy, Active cancer, Advanced organ failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves patients who have not improved with three antidepressants or anxiolytics, it might be possible to continue your current treatment. Please consult with the trial coordinators for specific guidance.

How is transcranial focused ultrasound treatment different from other treatments for depression and anxiety?

Transcranial focused ultrasound (tFUS) is unique because it is a non-invasive treatment that can precisely target deep brain structures with high spatial resolution, unlike other treatments that may require surgery or have less precise targeting. This makes it a promising option for patients who do not respond well to traditional therapies like medication or electroconvulsive therapy. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with refractory depression and anxiety.

Research Team

Sheldon Jordan, MD

Principal Investigator

Neurological Associates - the Interventional Group

Eligibility Criteria

This trial is for adults who have tried at least three antidepressants and anxiolytics without improvement, have a diagnosis of Major Depressive Disorder or Generalized/Acute Anxiety Disorder, and score high on anxiety and depression scales.

Inclusion Criteria

You have a score of more than 13 on a test called the Beck Depression Inventory.

I have tried 3 different anxiety medications without success.

I have tried 3 antidepressants without success.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial focused ultrasound treatment for depression and anxiety

8 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcranial Focused Ultrasound

Trial Overview The study is testing the use of transcranial focused ultrasound as a treatment. It's an open label study, meaning everyone knows they're getting the treatment, to see if it helps with severe depression and anxiety.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+

Findings from Research

Transcranial focused ultrasound (tFUS) is a promising non-surgical technique for neuromodulation that offers better spatial resolution compared to traditional electro and electromagnetic methods.

tFUS can effectively target sub-cortical brain structures non-invasively, and its combination with BOLD functional MRI allows for enhanced examination of brain activity in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound for BOLD fMRI signal modulation in humans. Leo Ai, ., Mueller, JK., Grant, A., et al.[2022]

Low-intensity focused ultrasound (LIFU) is a promising noninvasive technique for neuromodulation that could improve treatment outcomes for patients with Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD) who do not respond to traditional therapies.

Current psychosurgical techniques, such as deep-brain stimulation, have variable success rates, with only about half of patients showing adequate response, highlighting the need for innovative approaches like LIFU to enhance personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Definition of Surgical Targets in Major Depression and Obsessive-Compulsive Disorder: A Potential Role for Low-Intensity Focused Ultrasound? Guinjoan, SM.[2023]

The dual-crossed transducer system achieved high spatial resolution in targeting small brain regions in mice, with a focal volume of under 0.52 μm³ and a focal diameter of 1 mm, making it effective for precise neuromodulation.

In vivo experiments demonstrated successful brain stimulation in wild-type mice, evidenced by observable movements, confirming the system's capability for noninvasive and specific targeting of brain circuits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound stimulation with high spatial resolution. Kim, S., Jo, Y., Kook, G., et al.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A study of novel bilateral thermal capsulotomy with focused ultrasound for treatment-refractory obsessive-compulsive disorder: 2-year follow-up. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound for BOLD fMRI signal modulation in humans. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Personalized Definition of Surgical Targets in Major Depression and Obsessive-Compulsive Disorder: A Potential Role for Low-Intensity Focused Ultrasound? [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

A study of novel bilateral thermal capsulotomy with focused ultrasound for treatment-refractory obsessive-compulsive disorder: 2-year follow-up. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound stimulation with high spatial resolution. [2021]